BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1020345 · Received March 27, 2008

    Report

    Report Number
    2953161-2008-00054
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    December 21, 2005
    Report Date
    March 26, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PROXIMAL TYPE I ENDOLEAK. ALSO IMPLANTED IN THE PT PXC141000/LOT#03880361, PXA230300/LOT#040762114 AND PXA230300/LOT#03844859.

    Description of Event or Problem · 1

    AS REPORTED, IN 2005, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES FOR AN ABDOMINAL AORTIC ANEURYSM. A PROXIMAL TYPE I ENDOLEAK WAS FOUND AND REPAIR WAS ATTEMPTED WITH AN AORTIC EXTENDER COMPONENT. THE TYPE I ENDOLEAK WAS NOTED ON SUBSEQUENT EXAMS (PRIOR TO EVENT DATE, IN 2006, AND ONE MONTH LATER AND IN 2007). HOWEVER, THE ANEURYSM HAS DECREASED IN SIZE. PT WILL FOLLOW-UP YEARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W. L. GORE & ASSOCIATES, INC. WLG325 03762504

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| R